D-0148-2018 Class II Terminated
FDA drug recall D-0148-2018 was initiated by Vital Rx, Inc. dba Atlantic Pharmacy and Compounding on August 17, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility . The recall status is terminated (terminated April 29, 2020). Affected quantity: 61 Products.
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2017
- Initiation Date
- August 17, 2017
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 Products
Product Description
All Sterile Products within expiry
Reason for Recall
Lack of Assurance of Sterility .
Distribution Pattern
Nationwide.
Code Information
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products